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RU2010136302A - ANTI-CD79b ANTIBODIES AND IMMUNO CONJUGATES AND METHODS OF APPLICATION - Google Patents

ANTI-CD79b ANTIBODIES AND IMMUNO CONJUGATES AND METHODS OF APPLICATION Download PDF

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Publication number
RU2010136302A
RU2010136302A RU2010136302/10A RU2010136302A RU2010136302A RU 2010136302 A RU2010136302 A RU 2010136302A RU 2010136302/10 A RU2010136302/10 A RU 2010136302/10A RU 2010136302 A RU2010136302 A RU 2010136302A RU 2010136302 A RU2010136302 A RU 2010136302A
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RU
Russia
Prior art keywords
seq
sequence
amino acid
antibody
hvr
Prior art date
Application number
RU2010136302/10A
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Russian (ru)
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RU2553566C2 (en
Inventor
Ивонне ЧЭНЬ (US)
Ивонне ЧЭНЬ
Марк ДЕННИС (US)
Марк ДЕННИС
Дэвид ДОРНАН (US)
Дэвид ДОРНАН
Кристи ЭЛКИНС (US)
Кристи ЭЛКИНС
Джагатх Редди ДЖУНУТУЛА (US)
Джагатх Редди ДЖУНУТУЛА
Эндрю ПОЛСОН (US)
Эндрю Полсон
Бин ЧЖЭН (US)
Бин ЧЖЭН
Original Assignee
Дженентек, Инк. (Us)
Дженентек, Инк.
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Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40578652&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=RU2010136302(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from PCT/US2008/070088 external-priority patent/WO2009012268A1/en
Application filed by Дженентек, Инк. (Us), Дженентек, Инк. filed Critical Дженентек, Инк. (Us)
Publication of RU2010136302A publication Critical patent/RU2010136302A/en
Application granted granted Critical
Publication of RU2553566C2 publication Critical patent/RU2553566C2/en

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
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    • A61K31/537—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines spiro-condensed or forming part of bridged ring systems
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Abstract

1. Сконструированное анти-CD79b антитело с цистеиновыми заменами, содержащее одно или несколько свободных цистеинов и ! (a) по меньшей мере одну последовательность HVR, выбранную из группы, состоящей из: ! (i) HVR-L1, содержащей последовательность A1-A15, где A1-A15 представляет собой KASQSVDYDGDSFLN (SEQ ID NO:131); ! (ii) HVR-L2, содержащей последовательность B1-B7, где B1-B7 представляет собой AASNLES (SEQ ID NO:132); ! (iii) HVR-L3, содержащей последовательность C1-C9, где C1-C9 представляет собой QQSNEDPLT (SEQ ID NO:133); ! (iv) HVR-H1, содержащей последовательность D1-D10, где D1-D10 представляет собой GYTFSSYWIE (SEQ ID NO:134); ! (v) HVR-H2, содержащей последовательность E1-E18, где E1-E18 представляет собой GEILPGGGDTNYNEIFKG (SEQ ID NO:135); и ! (vi) HVR-H3, содержащей последовательность F1-F10, где F1-F10 представляет собой TRRVPVYFDY (SEQ ID NO:136); и ! (b) по меньшей мере один вариант HVR, где указанный вариант HVR имеет модификацию по меньшей мере в одном остатке последовательности, представленной в SEQ ID NO:131, 132, 133, 134, 135 или 136. ! 2. Сконструированное анти-CD79b антитело с цистеиновыми заменами, содержащее один или несколько свободных цистеинов и ! (а) вариабельный домен тяжелой цепи, содержащий последовательность HVR1-HC, HVR2-HC и/или HVR3-HC, представленную на фигуре 15 (SEQ ID NO:164-166), последовательность FR1-HC, FR2-HC, FR3-HC и/или FR4-HC, представленную на фигуре 15 (SEQ ID NO:160-163), и последовательность CH1 и/или Fc, представленную на фигуре 15 (SEQ ID NO:167 и/или 168); ! (b) вариабельный домен легкой цепи, содержащий последовательность HVR1-LC, HVR2-LC и/или HVR3-LC, представленную на фигуре 15 (SEQ ID NO:156-158), последовательность FR1-LC, FR2-LC, FR3-LC и/или FR4-LC, представленную на фигуре 15 (SEQ ID NO:152-155), и последовательность CL1, представленную на фигуре 15 (SEQ ID NO:159); ! (c) вариабельный домен тяжелой цепи, содержащий последовательн� 1. Designed anti-CD79b antibody with cysteine substitutions containing one or more free cysteines and! (a) at least one HVR sequence selected from the group consisting of:! (i) an HVR-L1 comprising the sequence A1-A15, where A1-A15 is KASQSVDYDGDSFLN (SEQ ID NO: 131); ! (ii) an HVR-L2 containing the sequence B1-B7, where B1-B7 is AASNLES (SEQ ID NO: 132); ! (iii) an HVR-L3 containing the sequence C1-C9, wherein C1-C9 is QQSNEDPLT (SEQ ID NO: 133); ! (iv) an HVR-H1 comprising the sequence D1-D10, wherein D1-D10 is GYTFSSYWIE (SEQ ID NO: 134); ! (v) an HVR-H2 containing the sequence E1-E18, where E1-E18 is GEILPGGGDTNYNEIFKG (SEQ ID NO: 135); and! (vi) an HVR-H3 comprising the sequence F1-F10, wherein F1-F10 is TRRVPVYFDY (SEQ ID NO: 136); and! (b) at least one HVR variant, wherein said HVR variant has a modification in at least one residue of the sequence shown in SEQ ID NO: 131, 132, 133, 134, 135 or 136.! 2. Designed anti-cysteine anti-CD79b antibody containing one or more free cysteines and! (a) the variable domain of the heavy chain containing the sequence HVR1-HC, HVR2-HC and / or HVR3-HC shown in figure 15 (SEQ ID NO: 164-166), the sequence FR1-HC, FR2-HC, FR3-HC and / or FR4-HC shown in FIG. 15 (SEQ ID NO: 160-163), and the sequence CH1 and / or Fc shown in FIG. 15 (SEQ ID NO: 167 and / or 168); ! (b) the variable domain of the light chain containing the sequence HVR1-LC, HVR2-LC and / or HVR3-LC shown in figure 15 (SEQ ID NO: 156-158), the sequence FR1-LC, FR2-LC, FR3-LC and / or FR4-LC shown in FIG. 15 (SEQ ID NO: 152-155), and the sequence CL1 shown in FIG. 15 (SEQ ID NO: 159); ! (c) the variable domain of the heavy chain containing the sequence�

Claims (12)

1. Сконструированное анти-CD79b антитело с цистеиновыми заменами, содержащее одно или несколько свободных цистеинов и1. Designed anti-CD79b antibody with cysteine substitutions containing one or more free cysteines and (a) по меньшей мере одну последовательность HVR, выбранную из группы, состоящей из:(a) at least one HVR sequence selected from the group consisting of: (i) HVR-L1, содержащей последовательность A1-A15, где A1-A15 представляет собой KASQSVDYDGDSFLN (SEQ ID NO:131);(i) an HVR-L1 comprising the sequence A1-A15, where A1-A15 is KASQSVDYDGDSFLN (SEQ ID NO: 131); (ii) HVR-L2, содержащей последовательность B1-B7, где B1-B7 представляет собой AASNLES (SEQ ID NO:132);(ii) an HVR-L2 containing the sequence B1-B7, where B1-B7 is AASNLES (SEQ ID NO: 132); (iii) HVR-L3, содержащей последовательность C1-C9, где C1-C9 представляет собой QQSNEDPLT (SEQ ID NO:133);(iii) an HVR-L3 containing the sequence C1-C9, wherein C1-C9 is QQSNEDPLT (SEQ ID NO: 133); (iv) HVR-H1, содержащей последовательность D1-D10, где D1-D10 представляет собой GYTFSSYWIE (SEQ ID NO:134);(iv) an HVR-H1 comprising the sequence D1-D10, wherein D1-D10 is GYTFSSYWIE (SEQ ID NO: 134); (v) HVR-H2, содержащей последовательность E1-E18, где E1-E18 представляет собой GEILPGGGDTNYNEIFKG (SEQ ID NO:135); и(v) an HVR-H2 containing the sequence E1-E18, where E1-E18 is GEILPGGGDTNYNEIFKG (SEQ ID NO: 135); and (vi) HVR-H3, содержащей последовательность F1-F10, где F1-F10 представляет собой TRRVPVYFDY (SEQ ID NO:136); и(vi) an HVR-H3 comprising the sequence F1-F10, wherein F1-F10 is TRRVPVYFDY (SEQ ID NO: 136); and (b) по меньшей мере один вариант HVR, где указанный вариант HVR имеет модификацию по меньшей мере в одном остатке последовательности, представленной в SEQ ID NO:131, 132, 133, 134, 135 или 136.(b) at least one HVR variant, wherein said HVR variant has a modification in at least one residue of the sequence shown in SEQ ID NO: 131, 132, 133, 134, 135 or 136. 2. Сконструированное анти-CD79b антитело с цистеиновыми заменами, содержащее один или несколько свободных цистеинов и2. Designed anti-CD79b antibody with cysteine substitutions containing one or more free cysteines and (а) вариабельный домен тяжелой цепи, содержащий последовательность HVR1-HC, HVR2-HC и/или HVR3-HC, представленную на фигуре 15 (SEQ ID NO:164-166), последовательность FR1-HC, FR2-HC, FR3-HC и/или FR4-HC, представленную на фигуре 15 (SEQ ID NO:160-163), и последовательность CH1 и/или Fc, представленную на фигуре 15 (SEQ ID NO:167 и/или 168);(a) the variable domain of the heavy chain containing the sequence HVR1-HC, HVR2-HC and / or HVR3-HC shown in figure 15 (SEQ ID NO: 164-166), the sequence FR1-HC, FR2-HC, FR3-HC and / or FR4-HC shown in FIG. 15 (SEQ ID NO: 160-163), and the sequence CH1 and / or Fc shown in FIG. 15 (SEQ ID NO: 167 and / or 168); (b) вариабельный домен легкой цепи, содержащий последовательность HVR1-LC, HVR2-LC и/или HVR3-LC, представленную на фигуре 15 (SEQ ID NO:156-158), последовательность FR1-LC, FR2-LC, FR3-LC и/или FR4-LC, представленную на фигуре 15 (SEQ ID NO:152-155), и последовательность CL1, представленную на фигуре 15 (SEQ ID NO:159);(b) the variable domain of the light chain containing the sequence HVR1-LC, HVR2-LC and / or HVR3-LC shown in figure 15 (SEQ ID NO: 156-158), the sequence FR1-LC, FR2-LC, FR3-LC and / or FR4-LC shown in FIG. 15 (SEQ ID NO: 152-155), and the sequence CL1 shown in FIG. 15 (SEQ ID NO: 159); (c) вариабельный домен тяжелой цепи, содержащий последовательность HVR1-HC, HVR2-HC и/или HVR3-HC, представленную на фигуре 16 (SEQ ID NO:183-185), последовательность FR1-HC, FR2-HC, FR3-HC и/или FR4-HC, представленную на фигуре 16 (SEQ ID NO:179-182), и последовательность CH1 и/или Fc, представленную на фигуре 16 (SEQ ID NO:186 и/или 187);(c) the variable domain of the heavy chain containing the sequence HVR1-HC, HVR2-HC and / or HVR3-HC shown in figure 16 (SEQ ID NO: 183-185), the sequence FR1-HC, FR2-HC, FR3-HC and / or FR4-HC shown in FIG. 16 (SEQ ID NO: 179-182), and the sequence CH1 and / or Fc shown in FIG. 16 (SEQ ID NO: 186 and / or 187); (d) вариабельный домен легкой цепи, содержащий последовательность HVR1-LC, HVR2-LC и/или HVR3-LC, представленную на фигуре 16 (SEQ ID NO:175-177), вариабельный домен включает последовательность FR1-LC, FR2-LC, FR3-LC и/или FR4-LC, представленную на фигуре 16 (SEQ ID NO:171-174), и последовательность CL1, представленную на фигуре 16 (SEQ ID NO:178);(d) the variable domain of the light chain containing the sequence HVR1-LC, HVR2-LC and / or HVR3-LC shown in figure 16 (SEQ ID NO: 175-177), the variable domain includes the sequence FR1-LC, FR2-LC, FR3-LC and / or FR4-LC shown in FIG. 16 (SEQ ID NO: 171-174), and the CL1 sequence shown in FIG. 16 (SEQ ID NO: 178); (e) вариабельный домен тяжелой цепи, содержащий последовательность HVR1-HC, HVR2-HC и/или HVR3-HC, представленную на фигуре 17 (SEQ ID NO:202-204), последовательность FR1-HC, FR2-HC, FR3-HC и/или FR4-HC, представленную на фигуре 17 (SEQ ID NO:198-201), и последовательность CH1 и/или Fc, представленную на фигуре 17 (SEQ ID NO:205 и/или 206);(e) the variable domain of the heavy chain containing the sequence HVR1-HC, HVR2-HC and / or HVR3-HC shown in figure 17 (SEQ ID NO: 202-204), the sequence FR1-HC, FR2-HC, FR3-HC and / or FR4-HC shown in FIG. 17 (SEQ ID NO: 198-201), and the sequence CH1 and / or Fc shown in FIG. 17 (SEQ ID NO: 205 and / or 206); (f) вариабельный домен легкой цепи, содержащий последовательность HVR1-LC, HVR2-LC и/или HVR3-LC, представленную на фигуре 17 (SEQ ID NO:194-196), последовательность FR1-LC, FR2-LC, FR3-LC и/или FR4-LC, представленную на фигуре 17 (SEQ ID NO:190-193), и последовательность CL1, представленную на фигуре 17 (SEQ ID NO:197);(f) the variable domain of the light chain containing the sequence HVR1-LC, HVR2-LC and / or HVR3-LC shown in figure 17 (SEQ ID NO: 194-196), the sequence FR1-LC, FR2-LC, FR3-LC and / or FR4-LC shown in FIG. 17 (SEQ ID NO: 190-193), and the sequence CL1 shown in FIG. 17 (SEQ ID NO: 197); (g) вариабельный домен тяжелой цепи, содержащий последовательность HVR1-HC, HVR2-HC и/или HVR3-HC, представленную на фигуре 18 (SEQ ID NO:221-223), последовательность FR1-HC, FR2-HC, FR3-HC и/или FR4-HC, представленную на фигуре 18 (SEQ ID NO:217-220), и последовательность CH1 и/или Fc, представленную на фигуре 18 (SEQ ID NO:224 и/или 225); или(g) the variable domain of the heavy chain containing the sequence HVR1-HC, HVR2-HC and / or HVR3-HC shown in figure 18 (SEQ ID NO: 221-223), the sequence FR1-HC, FR2-HC, FR3-HC and / or FR4-HC shown in FIG. 18 (SEQ ID NO: 217-220), and the sequence CH1 and / or Fc shown in FIG. 18 (SEQ ID NO: 224 and / or 225); or (h) вариабельный домен легкой цепи, включающий последовательность HVR1-LC, HVR2-LC и/или HVR3-LC, представленную на фигуре 18 (SEQ ID NO:213-215), последовательность FR1-LC, FR2-LC, FR3-LC и/или FR4-LC, представленную на фигуре 18 (SEQ ID NO:209-212), и последовательность CL1, представленную на фигуре 18 (SEQ ID NO:216).(h) a light chain variable domain comprising the sequence HVR1-LC, HVR2-LC and / or HVR3-LC shown in FIG. 18 (SEQ ID NO: 213-215), the sequence FR1-LC, FR2-LC, FR3-LC and / or FR4-LC shown in FIG. 18 (SEQ ID NO: 209-212), and the sequence CL1 shown in FIG. 18 (SEQ ID NO: 216). 3. Сконструированное анти-CD79b антитело с цистеиновыми заменами, содержащее один или несколько свободных цистеинов и3. Designed anti-CD79b antibody with cysteine substitutions containing one or more free cysteines and (a) вариабельный домен тяжелой цепи, имеющий аминокислотную последовательность, которая по меньшей мере на 90% идентична аминокислотной последовательности, выбранной из SEQ ID NO:170, и вариабельный домен легкой цепи, имеющий аминокислотную последовательность, которая по меньшей мере на 90% идентична аминокислотной последовательности, выбранной из SEQ ID NO:169;(a) a heavy chain variable domain having an amino acid sequence that is at least 90% identical to an amino acid sequence selected from SEQ ID NO: 170, and a light chain variable domain having an amino acid sequence that is at least 90% identical to an amino acid a sequence selected from SEQ ID NO: 169; (b) вариабельный домен тяжелой цепи, имеющий аминокислотную последовательность, которая по меньшей мере на 90% идентична аминокислотной последовательности, выбранной из SEQ ID NO:189, вариабельный домен легкой цепи, имеющий аминокислотную последовательность, которая по меньшей мере на 90% идентична аминокислотной последовательности, выбранной из SEQ ID NO:188;(b) a heavy chain variable domain having an amino acid sequence that is at least 90% identical to an amino acid sequence selected from SEQ ID NO: 189, a light chain variable domain having an amino acid sequence that is at least 90% identical to an amino acid sequence selected from SEQ ID NO: 188; (c) вариабельный домен тяжелой цепи, имеющий аминокислотную последовательность, которая по меньшей мере на 90% идентична аминокислотной последовательности, выбранной из SEQ ID NO:208, вариабельный домен легкой цепи, имеющий аминокислотную последовательность, которая по меньшей мере на 90% идентична аминокислотной последовательности, выбранной из SEQ ID NO:207;(c) a heavy chain variable domain having an amino acid sequence that is at least 90% identical to an amino acid sequence selected from SEQ ID NO: 208, a light chain variable domain having an amino acid sequence that is at least 90% identical to an amino acid sequence selected from SEQ ID NO: 207; (d) вариабельный домен тяжелой цепи, имеющий аминокислотную последовательность, которая по меньшей мере на 90% идентична аминокислотной последовательности, выбранной из SEQ ID NO:227, вариабельный домен легкой цепи, имеющий аминокислотную последовательность, которая по меньшей мере на 90% идентична аминокислотной последовательности, выбранной из SEQ ID NO:226;(d) a heavy chain variable domain having an amino acid sequence that is at least 90% identical to an amino acid sequence selected from SEQ ID NO: 227, a light chain variable domain having an amino acid sequence that is at least 90% identical to an amino acid sequence selected from SEQ ID NO: 226; (е) вариабельный домен тяжелой цепи, имеющий аминокислотную последовательность, которая по меньшей мере на 90% идентична аминокислотной последовательности, выбранной из SEQ ID NO:301, вариабельный домен легкой цепи, имеющий аминокислотную последовательность, которая по меньшей мере на 90% идентична аминокислотной последовательности, выбранной из SEQ ID NO:302; или(e) a heavy chain variable domain having an amino acid sequence that is at least 90% identical to an amino acid sequence selected from SEQ ID NO: 301, a light chain variable domain having an amino acid sequence that is at least 90% identical to an amino acid sequence selected from SEQ ID NO: 302; or (f) вариабельный домен тяжелой цепи, имеющий аминокислотную последовательность, которая по меньшей мере на 90% идентична аминокислотной последовательности, выбранной из SEQ ID NO:14, вариабельный домен легкой цепи, имеющий аминокислотную последовательность, которая по меньшей мере на 90% идентична аминокислотной последовательности, выбранной из SEQ ID NO:10.(f) a heavy chain variable domain having an amino acid sequence that is at least 90% identical to an amino acid sequence selected from SEQ ID NO: 14, a light chain variable domain having an amino acid sequence that is at least 90% identical to an amino acid sequence selected from SEQ ID NO: 10. 4. Сконструированное антитело с цистеиновыми заменами, содержащее одну или несколько свободных цистеиновых аминокислот в одном или нескольких положениях, выбранных из положений 15, 110, 114, 121, 127, 168 и 205 легкой цепи в соответствии с нумерацией по Кэбату; положений 5, 23, 84, 112 тяжелой цепи в соответствии с нумерацией по Кэбату и положений 118, 120, 282, 375 и 400 тяжелой цепи в соответствии с Европейской нумерацией в родительском антителе, где указанным родительским антителом является антитело против CD79b, содержащее:4. Designed antibody with cysteine substitutions containing one or more free cysteine amino acids in one or more positions selected from positions 15, 110, 114, 121, 127, 168 and 205 of the light chain in accordance with the Kabat numbering; positions 5, 23, 84, 112 of the heavy chain in accordance with Kabat numbering and positions 118, 120, 282, 375 and 400 of the heavy chain in accordance with European numbering in the parent antibody, where the specified parent antibody is an anti-CD79b antibody containing: (a) по меньшей мере одну последовательность HVR, выбранную из группы, состоящей из:(a) at least one HVR sequence selected from the group consisting of: (i) HVR-L1, содержащей последовательность A1-A15, где A1-A15 представляет собой KASQSVDYDGDSFLN (SEQ ID NO:131);(i) an HVR-L1 comprising the sequence A1-A15, where A1-A15 is KASQSVDYDGDSFLN (SEQ ID NO: 131); (ii) HVR-L2, содержащей последовательность B1-B7, где B1-B7 представляет собой AASNLES (SEQ ID NO:132);(ii) an HVR-L2 containing the sequence B1-B7, where B1-B7 is AASNLES (SEQ ID NO: 132); (iii) HVR-L3, содержащей последовательность C1-C9, где C1-C9 представляет собой QQSNEDPLT (SEQ ID NO:133);(iii) an HVR-L3 containing the sequence C1-C9, wherein C1-C9 is QQSNEDPLT (SEQ ID NO: 133); (iv) HVR-H1, содержащей последовательность D1-D10, где D1-D10 представляет собой GYTFSSYWIE (SEQ ID NO:134);(iv) an HVR-H1 comprising the sequence D1-D10, wherein D1-D10 is GYTFSSYWIE (SEQ ID NO: 134); (v) HVR-H2, содержащей последовательность E1-E18, где E1-E18 представляет собой GEILPGGGDTNYNEIFKG (SEQ ID NO:135); и(v) an HVR-H2 containing the sequence E1-E18, where E1-E18 is GEILPGGGDTNYNEIFKG (SEQ ID NO: 135); and (vi) HVR-H3, содержащей последовательность F1-F10, где F1-F10 представляет собой TRRVPVYFDY (SEQ ID NO:136); и(vi) an HVR-H3 comprising the sequence F1-F10, wherein F1-F10 is TRRVPVYFDY (SEQ ID NO: 136); and (b) по меньшей мере один вариант HVR, где указанный вариант HVR имеет модификацию по меньшей мере в одном остатке последовательности, представленной в SEQ ID NO:131, 132, 133, 134, 135 или 136.(b) at least one HVR variant, wherein said HVR variant has a modification in at least one residue of the sequence shown in SEQ ID NO: 131, 132, 133, 134, 135 or 136. 5. Антитело по п.1, где указанное антитело ковалентно связывается с ауристатиновым или майтанзиноидным лекарственным средством, в результате чего образуется конъюгат «антитело-лекарственное средство».5. The antibody according to claim 1, where the specified antibody covalently binds to an auristatin or maytansinoid drug, resulting in the formation of an antibody-drug conjugate. 6. Конъюгат «антитело-лекарственное средство» по п.5, содержащий антитело (Ab) и молекулу ауристатинового или майтанзиноидного лекарственного средства (D), где указанное сконструированное антитело с цистеиновыми заменами связано с D линкерной молекулой (L) посредством одной или нескольких свободных цистеиновых аминокислот, где указанное соединение имеет формулу I:6. The antibody-drug conjugate according to claim 5, comprising an antibody (Ab) and an auristatin or maytansinoid drug molecule (D), wherein said engineered antibody with cysteine substitutions is linked to a D linker molecule (L) via one or more free cysteine amino acids, where the specified compound has the formula I :
Figure 00000001
Figure 00000001
 где p равно 1, 2, 3 или 4.where p is 1, 2, 3 or 4. 7. Соединение-конъюгат «антитело-лекарственное средство», выбранное из структур:7. The antibody-drug conjugate compound selected from the structures:
Figure 00000002
Figure 00000002
Figure 00000003
Figure 00000003
 где Val представляет собой валин; Cit представляет собой цитруллин; p равен 1, 2, 3 или 4; а Ab представляет собой антитело по п.191.where Val is a valine; Cit is citrulline; p is 1, 2, 3 or 4; and Ab is an antibody according to p. 8. Способ получения соединения-конъюгата «антитело-лекарственное средство», содержащего анти-CD79b антитело (Ab) по п.1 и молекулу ауристатинового или майтанзиноидного лекарственного средства (D), где указанное антитело связано с D с помощью линкерной молекулы (L) через одну или несколько цистеновых замен, где указанное соединение имеет формулу I:8. A method of producing a antibody-drug conjugate compound comprising an anti-CD79b antibody (Ab) according to claim 1 and an auristatin or maytansinoid drug molecule (D), wherein said antibody is coupled to D via a linker molecule (L) through one or more cystene substitutions, where the specified compound has the formula I:
Figure 00000004
Figure 00000004
 где p равно 1, 2, 3 или 4, и где указанный способ включает стадии:where p is 1, 2, 3 or 4, and where the specified method includes the steps of: (a) реакции взаимодействия цистеиновой группы, введенной в сконструированное антитело с цистеиновыми заменами, с линкерным реагентом, с образованием промежуточного соединения антитело-линкер Ab-L; и(a) a reaction of interaction of a cysteine group introduced into the engineered antibody with cysteine substitutions with a linker reagent to form an antibody-linker Ab-L intermediate; and (b) реакции взаимодействия Ab-L с активированной молекулой лекарственного средства D с образованием конъюгата «антитело-лекарственное средство»; или стадии:(b) an Ab-L interaction with an activated drug molecule D to form an antibody-drug conjugate; or stage: (c) реакции взаимодействия нуклеофильной группы молекулы лекарственного средства с линкерным реагентом с образованием промежуточного соединения «лекарственное средство-линкер» D-L; и(c) a reaction between a nucleophilic group of a drug molecule and a linker reagent to form a drug-linker intermediate D-L; and (d) реакции взаимодействия D-L с цистеиновой группой, введенной в сконструированное антитело с цистеиновыми заменами, с образованием конъюгата «антитело-лекарственное средство».(d) the reaction of the interaction of D-L with a cysteine group introduced into the engineered antibody with cysteine substitutions, with the formation of the conjugate "antibody-drug." 9. Композиция, содержащая антитело по п.1.9. The composition containing the antibody according to claim 1. 10. Фармацевтический состав, содержащий конъюгат «антитело-лекарственное средство» по п.7 и фармацевтически приемлемый разбавитель, носитель или эксципиент.10. A pharmaceutical composition comprising an antibody-drug conjugate according to claim 7 and a pharmaceutically acceptable diluent, carrier or excipient. 11. Сконструированное анти-CD79b антитело с цистеиновыми заменами по п.10, содержащее одну или несколько последовательностей, выбранных из:11. Designed anti-CD79b antibody with cysteine substitutions of claim 10, containing one or more sequences selected from: Последовательность возле Cys-мутацииSequence Near Cys Mutation Номер в последовательностиSequence Number Нумерация по КабатKabat numbering EU-нумерацияEU numbering SEQ ID NOSEQ ID NO SLSASCGDRVTSLSASCGDRVT V15CV15c V15CV15c   278278 EIKRTCAAPSVEIKRTCAAPSV V114CV114C V110CV110C   279279 FIFPPCDEQLKFIFPPCDEQLK S125CS125C S121CS121C   281281 DEQLKCGTASVDEQLKCGTASV S131CS131C S127CS127C   282282 VTEQDCKDSTYVTEQDCKDSTY S172CS172C S168CS168C   283283 GLSSPCTKSFNGLSSPCTKSFN V209CV209C V205CV205c   284284
12. Сконструированное анти-CD79b антитело с цистеиновыми заменами по п.11, содержащее последовательность тяжелой цепи, выбранную из: SEQ ID NO: 308, 304, 306 и 310,12. Designed anti-CD79b antibody with cysteine substitutions according to claim 11, containing a heavy chain sequence selected from: SEQ ID NO: 308, 304, 306 and 310, и/илиand / or последовательность легкой цепи, выбранную из: SEQ ID NO:307, 303, 305 и 309. a light chain sequence selected from: SEQ ID NO: 307, 303, 305, and 309.
RU2010136302/10A 2008-01-31 2009-01-14 ANTI-CD79b ANTIBODIES AND IMMUNOCONJUGATES AND METHODS FOR USING THEM RU2553566C2 (en)

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